BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19373609 · Received May 22, 2024

    Report

    Report Number
    3013682457-2024-00010
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 22, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS CONDUCTED ON THE REPORTED INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE. INVESTIGATION OF THE GUARDIAN SYSTEM DATA INDICATES THE USER CLEARED MULTIPLE PINCH ALERTS WITHOUT RESOLVING THE ISSUE. HOWEVER, IT CANNOT BE DETERMINED WHETHER THIS CAUSED OR CONTRIBUTED TO THE INJURY OBSERVED.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON 05-APR-2024 A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE NATAL CLEFT. IT WAS NOTED THE INJURY PROGRESSED FROM A MASD TO A STAGE 3 PRESSURE INJURY. NO FURTHER DETAILS WERE REPORTED REGARDING THE REASON FOR PATIENT HOSPITAL ADMISSION, OR WITH REGARDS TO OUTCOMES FROM THE STAGE 3 INJURY OBSERVED. REVIEW OF THE GUARDIAN SYSTEM DATA NOTED MULTIPLE PINCH ALERT "AIRFLOW BLOCKED" EVENTS, ACCOUNTING FOR A TOTAL OF 14.68 HOURS OF GAPS IN THERAPY (27% OF TOTAL GAPS IN THERAPY) FROM ADMISSION TO INJURY DISCOVERY. IT WAS ALSO NOTED THE PINCH ALERTS WERE CLEARED MULTIPLE TIMES BY THE USER WITHOUT RESOLUTION. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608871 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown